3 ms·

I want to upvote your comment ten times, but there's only one of me. Thanks for the point of view, history, and references. Why, do you think, are the pharma r

I want to upvote your comment ten times, but there's only one of me. Thanks for the point of view, history, and references. Why, do you think, are the pharma researchers not shifting cutting edge research to places where regulation is more pliable and inventing new treatments there. Surely Latin America or China (maybe even India, depending on bureaucracy) could provide the kind of market and test bed for new treatments that fast innovation would thrive in.

ramanujan 15y ago
Good question. In theory this is possible, and there are a number of biotechs and medical device companies that are looking overseas. Europe is the preferred place right now for traditional biotechs & medical device companies, as getting a CE Mark is a lot less onerous and much more predictable[0] than the increasingly random FDA process. As for China (and India), they are very promising but will require entirely new business models, for a few reasons. First, the current biotech industry is based around an artificial barrier to entry (namely FDA approval) and artificial scarcity (namely drug patents). Remove the former and you remove the rationale for the latter. This is their whole business model. Second and more fundamentally, most existing pharma companies have now gone through almost 50 years with the FDA. The "fail fast" model was 2-3 human generations ago, and even really good scientists like Derek Lowe have a bit of Stockholm Syndrome. In the worldview of (most) modern pharma scientists, the FDA process is considered a law of nature, something on par with s and p orbitals. Removing FDA approval and patents from the situation would suddenly make two of the most important departments in any pharma company (regulatory affairs and IP) completely useless. A world without the FDA, where doctor, patient, and chemist made their own decisions without third party regulation would be painted as strange and worrisome. Like the TSA, the FDA has dozens of full time PR professionals[1,2] dedicated to convincing you that "your safety is their priority". Unlike the TSA, most people (even most in the industry) don't question whether the FDA is actually protecting people. Without going into detail, then, successful business models for pharma/biotech/device companies in China/India would be based on validating products in a highly empirical fashion, getting them to market rapidly and protecting them from competitors via execution without any IP enforcement. Think something more like the supplements market, where creatine, omega 3, and energy drinks rose to the fore over the last few decades...except with even smarter people doing the formulations. No traditional pharma is culturally capable of doing this. Moreover, even if they were, the FDA would frown on this threat to their review authority. If this hypothetical rogue pharma had any desires of ever selling into the US market or not having their reputation destroyed by the FDA with a few press releases, they wouldn't try setting up this sort of low-regulation phenomenological branch overseas. So, to really exploit the potential of true drug legalization, it'd have to be new companies. [0] http://www.eurekalert.org/pub_releases/2011-05/iti-fpa052311.php http://www.eurekalert.org/pub_releases/2011-05/iti-fpa052311... [1] http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default.htm http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default... [2] http://www.fda.gov/AboutFDA/ContactFDA/FindanOfficeorStaffMember/FDAPublicAffairsSpecialists/default.htm http://www.fda.gov/AboutFDA/ContactFDA/FindanOfficeorStaffMe...
- WildUtah 15y ago
  Thank you for writing an informative reply to my question. It's a lot to think about.

ramanujan 15y ago

Good question. In theory this is possible, and there are a number of biotechs and medical device companies that are looking overseas. Europe is the preferred place right now for traditional biotechs & medical device companies, as getting a CE Mark is a lot less onerous and much more predictable[0] than the increasingly random FDA process. As for China (and India), they are very promising but will require entirely new business models, for a few reasons. First, the current biotech industry is based around an artificial barrier to entry (namely FDA approval) and artificial scarcity (namely drug patents). Remove the former and you remove the rationale for the latter. This is their whole business model. Second and more fundamentally, most existing pharma companies have now gone through almost 50 years with the FDA. The "fail fast" model was 2-3 human generations ago, and even really good scientists like Derek Lowe have a bit of Stockholm Syndrome. In the worldview of (most) modern pharma scientists, the FDA process is considered a law of nature, something on par with s and p orbitals. Removing FDA approval and patents from the situation would suddenly make two of the most important departments in any pharma company (regulatory affairs and IP) completely useless. A world without the FDA, where doctor, patient, and chemist made their own decisions without third party regulation would be painted as strange and worrisome. Like the TSA, the FDA has dozens of full time PR professionals[1,2] dedicated to convincing you that "your safety is their priority". Unlike the TSA, most people (even most in the industry) don't question whether the FDA is actually protecting people. Without going into detail, then, successful business models for pharma/biotech/device companies in China/India would be based on validating products in a highly empirical fashion, getting them to market rapidly and protecting them from competitors via execution without any IP enforcement. Think something more like the supplements market, where creatine, omega 3, and energy drinks rose to the fore over the last few decades...except with even smarter people doing the formulations. No traditional pharma is culturally capable of doing this. Moreover, even if they were, the FDA would frown on this threat to their review authority. If this hypothetical rogue pharma had any desires of ever selling into the US market or not having their reputation destroyed by the FDA with a few press releases, they wouldn't try setting up this sort of low-regulation phenomenological branch overseas. So, to really exploit the potential of true drug legalization, it'd have to be new companies. [0] http://www.eurekalert.org/pub_releases/2011-05/iti-fpa052311.php http://www.eurekalert.org/pub_releases/2011-05/iti-fpa052311... [1] http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default.htm http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default... [2] http://www.fda.gov/AboutFDA/ContactFDA/FindanOfficeorStaffMember/FDAPublicAffairsSpecialists/default.htm http://www.fda.gov/AboutFDA/ContactFDA/FindanOfficeorStaffMe...

WildUtah 15y ago
Thank you for writing an informative reply to my question. It's a lot to think about.